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REGISTERING YOUR STUDY ON CLINICALTRIALS*GOV I. BACKGROUND Clinical Trials registration is public disclosure of key information of a clinical trial* The US Food and Drug Administration FDA the International Committee of Medical Journal Editors ICMJE and the World Health Organization WHO are just a few of the groups calling for clinical trials registration* In 1997 the Food and Drug Administration Modernization Act FDAMA required registration of certain clinical trials in a national database...
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How to fill out registering your study on
How to fill out Registering Your Study on ClinicalTrials.gov
01
Visit the ClinicalTrials.gov website.
02
Create an account or log in if you already have one.
03
Click on 'Register' to start a new study registration.
04
Fill out the study identification information, including the title, brief summary, and study design.
05
Provide the study status, including the enrollment phase and eligibility criteria.
06
Enter sponsor and collaborator information, as well as the study's funding sources.
07
Detail the intervention and outcomes, specifying primary and secondary outcomes.
08
Review all entered information for accuracy and completeness.
09
Submit the registration for review.
10
Once reviewed, make any recommended changes and finalize the registration.
Who needs Registering Your Study on ClinicalTrials.gov?
01
Researchers conducting clinical studies.
02
Institutions or organizations sponsoring clinical trials.
03
Study investigators involved in clinical research.
04
Regulatory bodies that require transparency in clinical research.
05
Patients looking for information on ongoing or upcoming clinical trials.
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People Also Ask about
How long does it take for a clinical trial to be approved?
This process can take a long time — in most cases, an average of 10 years will pass between initial discovery to full approval, with the clinical trial stages taking six to seven years of that time.
Is registration of clinical trials really needed?
To substantially minimize the instances of misconducts in research studies, the clinical trial should be registered prospectively before starting the recruitment process.
Which clinical trials pay the most money?
The therapeutic area can also impact payment — cardiovascular disease, neurology, endocrine, gastrointestinal, and blood disorders trials tend to pay the most. However, it's important to remember that paid clinical trials ask for something in return.
When must a clinical trial be registered?
When must clinical trials be registered? Federal regulations require that applicable clinical trials and NIH-funded clinical trials be registered no later than 21 days after enrollment of the first participant.
Why do 90% of clinical trials fail?
Design Flaws: Poorly designed trials with inadequate sample sizes, incorrect choice of primary endpoints, or improper patient selection can lead to inconclusive or negative results.
How do you set up a clinical study?
Key Steps to the Study Startup Stage Building a Budget. Designing a Protocol. Signing a Startup Agreement. Initiating Documentation. Customizing Kits for Sites. Be Responsive and Timely about Getting Documents Finalized. Be Open to Collaboration. Have Important Site Information Ready.
How long does it take to publish a clinical trial?
DISCUSSION. We found, on average, nearly two years passed between completion and publication of clinical trials, across all trial funders. Moreover, given our study was necessarily limited to examining time to publication among completed trials that were eventually published, this estimate is conservative.
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What is Registering Your Study on ClinicalTrials.gov?
Registering your study on ClinicalTrials.gov involves submitting detailed information about a clinical trial to a publicly accessible database. This ensures transparency and allows the public to access key information about the trial.
Who is required to file Registering Your Study on ClinicalTrials.gov?
Researchers and sponsors of clinical trials, particularly those that are federally funded or are subject to FDA regulations, are required to register their studies on ClinicalTrials.gov.
How to fill out Registering Your Study on ClinicalTrials.gov?
To fill out the registration, users must provide details such as the study's title, objectives, eligibility criteria, locations, and contact information. The process is completed through the ClinicalTrials.gov online system.
What is the purpose of Registering Your Study on ClinicalTrials.gov?
The purpose is to promote transparency, enhance participant safety, facilitate data sharing, and prevent publication bias by making information about clinical trials available to the public.
What information must be reported on Registering Your Study on ClinicalTrials.gov?
The registration must include information such as the study's title, purpose, design, outcomes, eligibility criteria, recruitment status, and contact details for the responsible party.
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